| Action | Amendment 3 |
| Stage | Proposed |
| Comment Period | Ended on 4/18/2022 |
 |
Ms. Priscilla D. Rohrer
Guidance and Regulation Coordinator
Virginia Department of Environmental Quality
P. O. Box 3000
Harrisonburg, VA 22801
Dear Ms. Rohrer:
SUBJECT: DEPARTMENT OF DEFENSE COMMENTS ON VIRGINIA REGULATED
MEDICAL WASTE MANAGEMENT REGULATIONS
As the Department of Defense (DoD) Regional Environmental Coordinator (REC) for U.S. Environmental Protection Agency (EPA) Region III, Commander, Navy Region Mid-Atlantic is responsible for coordinating responses to state environmental legislative and regulatory matters of interest on behalf of the military services. The DoD takes very seriously its dual responsibility to carry out its military mission while protecting the environment.
The DoD appreciates the opportunity to provide comments for consideration in response to proposed Regulated Medical Waste Management Regulations (repealing 9VAC20-120-10 through 9VAC20-120-1000 and adding 9VAC20-121-10 through 9VAC20-121-420). The enclosure provides DoD comments that will provide clarifications and recommended corrections to the regulations once adopted.
Thank you in advance for the opportunity to provide comments. If you have any questions, you may contact Ms. Bernadette Reese at bernadette.w.reese.civ@us.navy.mil; or Commander Gretchen Sosbee at gretchen.d.sosbee.mil@us.navy.mil.
Sincerely,
SHARON L. BAUMANN
Director for Regional
Environmental Coordination
By direction of the Commander
Enclosure: 1. Department of Defense Comments on Regulated Medical Waste
Management Regulations
Copy to:
U.S. Army REC, Region III (Dr. James Hartman)
U.S. Air Force REC, Region III (Mr. Alan Roberts)
Department of Defense Comments
Virginia Regulated Medical Waste Management Regulations
The Department of Defense (DoD) submits the attached comments on the proposed Virginia Regulated Medical Waste Management Regulations.
Comment:
The DoD is concerned that the definition does not fully encompass the U.S. Department of Transportation definition of hazardous material and may result in confusion to the reader.
Discussion:
The U.S. Department of Transportation definition of hazardous material is more definitive and descriptive.
Recommendation:
The following revision to the definition of a “Hazardous Material” is provided for consideration in order to provide clarity.
Recommended Definition:
"Hazardous material” means a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and is designated as hazardous under section 5103 of the Federal hazardous materials transportation law (49 U.S.C. 5103).
Comment:
The DoD is concerned that the definition, as written, is more inclusive than needed for protection of human health for the discard of unused sharps contained in its original inner and outer packaging.
Discussion:
Including discarded unused sharps contained in its original inner and outer packaging subjects these items to the Regulated Medical Waste regulations that provide no additional protection of human health. The industry standard for treating sharps is autoclaving, followed by placement in landfills. Excluding unused sharps from 9VAC20-121-10 would maintain consistency with the Department of Transportation’s definition of sharps in 49 CFR 173.134(a)(6).
Recommendation:
The following revision to the definition of “Sharps” is provided for consideration along with the regulatory citation, 49 CFR 173.134(a)(6):
Recommended Definition:
"Sharps" means needles, scalpels, knives, lancets, syringes with attached needles, suture needles, pasteur pipettes, broken glass, broken rigid plastic, and similar items having a point or sharp edge or that are likely to cause percutaneous injury or break during transportation and result in a point or sharp edge that may puncture or compromise the integrity of the container. Discarded unused sharps contained in its original liner and outer packaging are excluded from this definition.
49 CFR 173.134(a)(6)
Sharps means any object contaminated with a pathogen or that may become contaminated with a pathogen through handling or during transportation and also capable of cutting or penetrating skin or a packaging material. Sharps includes needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires.
Comment:
The DoD is concerned that the regulation does not provide definitive guidance that clarifies the packaging and labeling standard.
Discussion:
The packaging and labeling standard should meet the current United Nations standards/provisions for UN3549, Category A waste, and not the older standards used during the Ebola crisis.
Recommendation:
The following revision to 9VAC20-121-160.C is provided for consideration to provide additional clarity.
Recommended Language:
Waste Transporter Information and Responsibilities for Category A waste are specified in Section 6 of Managing Solid Waste Contaminated with a Category A Infectious Substance. Packaging and labeling of Category A waste for transport must comply with the “packaging and labeling provisions applicable to United Nations requirements noted under UN3549, “Medical waste, category A, affecting animals only, solid” or “Medical waste, category A, affecting humans, solid”.
Comment:
The word “noncombustible” should replace “noncombustion” for correctness.
Comment:
The DoD is concerned that the regulation does not provide clarity for operation of any treatment unit.
Discussion:
The regulation is too generic and may not include specific information for operation of any treatment unit.
Recommendation:
The following revision to 9VAC20-121-240.B.8 is provided for your consideration:
Recommended Language:
Prior to operation of any treatment unit, the facility must conduct validation testing in accordance with 9VAC20-121-260 and an approved treatment plan to establish the appropriate operating parameters for effective treatment of regulated medical waste. The results of the testing must be submitted to the department for review and approval in accordance with 9VAC20-121-320. The facility shall not receive or treat regulated medical waste until the department has approved the validation results, operating parameters, and protocols to be used for the treatment unit. Revalidation shall be conducted as required by 9VAC20-121-260. Use of bioassays to validate the effectiveness of toxin inactivation is necessary to meet required protocols and should not be assumed.